Intraluminal tissue modifying systems and associated devices and methods

ABSTRACT

The present technology is directed generally to devices, systems, and methods for capturing and cutting fibrous and trabeculated structures (such as synechiae) in vessel lumens. In one embodiment, the present technology includes an intraluminal tissue modifying system configured to capture the fibrous structures, put the fibrous structures in tension, and controllably cut through the fibrous structures without applying appreciable additional force to the vessel wall. The system may include an expandable capture device and a cutting device.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.15/478,143, filed Apr. 3, 2017, now pending, which claims the benefit ofU.S. Provisional Patent Application No. 62/317,470 filed on Apr. 1,2016, entitled INTRALUMINAL TISSUE MODIFYING SYSTEMS AND ASSOCIATEDDEVICES AND METHODS, and claims the benefit of U.S. Provisional PatentApplication No. 62/347,186 filed on Jun. 8, 2016, entitled INTRALUMINALTISSUE MODIFYING SYSTEMS AND ASSOCIATED DEVICES AND METHODS, all ofwhich are incorporated herein by reference in their entireties.

TECHNICAL FIELD

The present technology is directed generally to intraluminal tissuemodifying systems and associated devices and methods.

BACKGROUND

There exists a disease condition in the leg veins called venoussynechiae or septae, also called trabeculated or fenestrated veins. Allof the foregoing terms refer to flow-obstructing structures present inhuman veins which are thought to be residual intraluminal scar tissueresulting from long-term presence of fibrotic thrombus. Afterthrombolysis, either through natural lysis or treatment viathrombolytics or thrombectomy, fibrous structures often remain. Thispartial obstruction of flow leads to clinical conditions such ashypertension, edema, chronic pain, and non-healing ulcers. The conditionis also a risk for further thrombosis, and can also prevent or interferewith interventions such as balloon angioplasty or stenting.

Venous synechiae restrict blood flow via two mechanisms: (1) reductionof the effective luminal cross-sectional area due to their physicalpresence, and (2) reduction of the overall venous luminal diametercaused by stored tension in the synechiae that pulls the vessel wallsinward. Puggioni et al carried out endophlebectomies, or removal ofvenous synechiae, on 13 patients in an open surgical fashion. In thisexperience, Puggioni describes the second, more subtle obstructiveimpact of venous synechiae: “After removal of the synechiae, an increasein luminal diameter is observed as a result of the release ofconstricting bands, and this contributes to improved vessel compliance.”Puggioni et al. Surgical disobliteration of postthrombotic deepveins—endophlebectomy—is feasible. J Vasc Surg 2004; 39:1048-52.

While complete removal of venous synechiae may be ideal for maximizingrestoration of flow to a venous lumen, there is a clinical benefit torelieving the tension imposed on the vessel wall by cutting thesynechiae. Cutting the synechiae also enables intraluminal delivery of aballoon catheter or stent delivery system which can then be deployed toexpand the vessel (via dilation or stenting).

Individual synechiae are often tough and fibrous in nature, and can alsobe quite dense in the vessel lumen. Current methods for treating orotherwise reducing the physiological impact of the synechiae include theuse of cutting balloons, balloon angioplasty, or stenting to cut throughthe fibrous synechiae structures. However, such methods have proven tohave limited efficacy on restoring flow due to the toughness and/ordensity of the obstructions. Direct surgical excision of the synechiaehave also been attempted but open vascular surgical procedures canthemselves lead to post-surgical complications such as hematoma,infection, thrombosis, or restenosis. Furthermore, a direct surgicalapproach cannot easily treat long lengths of veins or multiple sites inone patient without causing increased trauma to the patient.

One existing approach for cutting intraluminal fibers involves a devicewith a grasping component and a tubular member with internal cuttingdevices. In this approach, the grasper pulls fibers into the tubularmember where they are severed on contact with the cutting devices.However, the design of such a device has limited ability to cut acrossthe entire diameter of a vessel, or to cut through the bulk of fibrousmaterial often seen in the veins. Other cutting catheter technologyexists, such as cutting balloons, atherectomy devices, chronic totalocclusion catheter, or embolectomy catheters. However, none of thesedevices were designed for cutting fibrous and bulky intravascularstructures, and are therefore limited in their ability to treat theseconditions. Devices such as valvulotomes are designed to remove existingvalves from veins, for example in procedures utilizing veins inconnection with in situ bypass graft placement or treating AV fistulas.However, vein valves are relatively thin structures and valvulotomedevices are not designed to cut particularly tough tissue. As such,valvutome devices would be unsuitable for cutting tissue structures suchas venous synechiae. Also, these technologies require the user to pullthe device past the tissue in order to cut, thus applying a shear forceon the vessel wall and surrounding tissue. If there is any resistance tocutting, the applied force may result in considerable pain to thepatient. Even in cases requiring minimal force, the act of cutting willresult in losing access across the treatment site and requiringre-accessing the site if the cuts were unsuccessful or inadequate on theinitial pass.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure.

FIG. 1 is a partially schematic overview of an intraluminal tissuemodifying system configured in accordance with the present technology,shown in a deployed state.

FIG. 2A is an isometric view of a distal portion of another embodimentof an intraluminal tissue modifying system configured in accordance withthe present technology, shown in a low-profile state.

FIGS. 2B-2D are isometric views of the distal portion of theintraluminal tissue modifying system shown in FIG. 2A, shown in severaldifferent deployed states.

FIGS. 3A and 3B are isometric views of a distal portion of anintraluminal tissue modifying system configured in accordance with thepresent technology, shown in a first deployed state and a seconddeployed state, respectively.

FIGS. 4 and 5 are isometric views of a distal portion of an intraluminaltissue modifying system configured in accordance with the presenttechnology, shown in a first deployed state and a second deployed state,respectively.

FIG. 6 is an isometric view of a distal portion of another embodiment ofan intraluminal tissue modifying system having tensioning armsconfigured in accordance with the present technology shown in a deployedstate.

FIGS. 7A-7C show several embodiments of intraluminal tissue modifyingsystems having capture members with different shapes in the deployedstate.

FIGS. 8A and 8B are isometric views of a distal portion of a capturedevice configured in accordance with the present technology, shown in alow-profile state and a deployed state, respectively.

FIG. 9A is a front view of a distal portion of a cutting deviceconfigured in accordance with the present technology, shown in adeployed state.

FIG. 9B is a front, isolated view of a portion of the cutting deviceshown in FIG. 9A.

FIG. 9C is an enlarged view of a portion of FIG. 9B.

FIG. 10 is an isometric view of a distal portion of a cutting deviceconfigured in accordance with the present technology, shown in adeployed state.

FIG. 11 is an isometric view of a distal portion of another embodimentof a cutting device configured in accordance with the presenttechnology, shown in a deployed state

FIGS. 12A and 12B are isometric views of a distal portion of a cuttingdevice configured in accordance with the present technology, shown in alow-profile state and a deployed state, respectively.

FIGS. 13A and 13B are isometric views of a distal portion of anotherembodiment of a cutting device configured in accordance with the presenttechnology, shown in a low-profile state and a deployed state,respectively.

FIGS. 14A-14C show several embodiments of cutting devices configured inaccordance with the present technology.

FIGS. 15A and 15B are isometric views of a distal portion of anintraluminal tissue modifying system configured in accordance with thepresent technology, shown in a low-profile state and a deployed state,respectively.

FIG. 16 is an isometric view of a distal portion of another embodimentof an intraluminal tissue modifying system having tensioning armsconfigured in accordance with the present technology shown in a deployedstate.

FIGS. 17 and 18 show further embodiments intraluminal modifying systemsconfigured in accordance with the present technology.

FIG. 19 shows another embodiment of an intraluminal tissue modifyingsystem configured in accordance with the present technology.

FIGS. 20A and 20B show another embodiment of an intraluminal tissuemodifying system configured in accordance with the present technology,shown during different stages of deployment.

FIG. 21 shows another embodiment of an intraluminal tissue modifyingsystem configured in accordance with the present technology.

FIG. 22A shows another embodiment of an intraluminal tissue modifyingsystem configured in accordance with the present technology.

FIG. 22B is a cross-sectional end view taken along line B-B in FIG. 22A.

FIG. 22C is a cross-sectional end view taken along line C-C in FIG. 22A.

FIG. 23 is a partially schematic overview of an intraluminal tissuemodifying system configured in accordance with the present technology,shown in a deployed state.

DETAILED DESCRIPTION

The present technology is directed generally to devices, systems, andmethods for capturing and cutting fibrous and trabeculated structures(such as synechiae) in vessel lumens. In one embodiment, the presenttechnology includes an intraluminal tissue modifying system configuredto capture the fibrous structures, put the fibrous structures intension, and controllably cut through the fibrous structures withoutapplying appreciable additional force to the vessel wall. As describedin greater detail below, the system includes an expandable capturedevice and a cutting device. The capture device and cutting device canbe separate components or can be integrated into the same component. Insome embodiments, the system can also be configured for use with one ormore visualization devices and/or therapeutic devices such as ballooncatheters, stents, and the like.

FIG. 1 is a partially schematic overview of one embodiment of anintraluminal tissue modifying system 100 (also referred to herein as“the system 100”) configured in accordance with the present technology,shown in a deployed state. As shown in FIG. 1, the system 100 has anelongated shaft 101, a distal portion 102 configured to be positioned ata treatment site within a blood vessel (e.g., a vein), and a proximalportion 104 configured to be positioned extracorporeally during theprocedure. The system 100 includes a handle 120 (shown schematically) atthe proximal portion 104. The distal portion 102 of the system 100includes a tissue modifying region 106. The tissue modifying region 106is transformable between a low-profile state (not shown) (e.g., fordelivery through an introducer sheath or other delivery device into avessel lumen) and an expanded or deployed state (shown in FIG. 1). Asshown in FIG. 1, the tissue modifying region 106 includes a capturedevice 108 and a cutting device 110. The capture device 108 can includeone or more capture members 116 that, in the deployed state, extendoutwardly away from a central longitudinal axis of the elongated shaft101 to engage fibrous structures at the treatment site. The cuttingdevice 110 can include one or more blades 130 that, in the deployedstate, extend outwardly away from the central longitudinal axis of theelongated shaft 101 to cut tissue at the treatment site.

Referring still to the embodiment shown in FIG. 1, the handle 120includes a first actuator 122 mechanically (e.g., via a push rod, pushtube, and/or pull-wire extending through the shaft 101) and/orelectrically (e.g., via one or more wires extending through the shaft101) coupled to the capture device 108 and a second actuator 124mechanically (e.g., via a push rod, push tube, and/or pull-wireextending through the shaft 101) and/or electrically coupled to thecutting device 110. Activation of the first actuator 122 deploys (e.g.,expands) the capture members 116 of the capture device 108, andactivation of the second actuator 124 deploys (e.g., expands) the blades130 of the cutting device 110. In some embodiments, the handle 120 alsoincludes a third actuator (not shown in FIG. 1) configured to move thecutting device 110 axially with respect to the capture device 108 (orvice versa). In a particular embodiment, the handle 120 may also includea connection to a flush line 126. The flush line can be fluidlyconnected to the distal portion 102 of the system 100 (e.g., via a lumenof the shaft 101).

In some methods of use, the system 100 can be introduced into the venoussystem from a proximal site (e.g., the femoral vein) and advanced in aretrograde direction (against normal blood flow) to a treatment site ina leg vein. The system 100 can be also be introduced into the venoussystem from a distal site (e.g., a popliteal or more distal vein) andadvanced in an antegrade direction (same direction as blood flow)towards the target treatment site.

FIGS. 2A-2D are isometric views of a distal portion of an intraluminaltissue modifying system 200 (“or modifying system 200”), shown indifferent states of deployment. Referring to FIGS. 2A-2D together, thesystem 200 includes a capture device 208 (only a distal portion shown)and a cutting device 210 (only a distal portion shown in FIGS. 2C and2D) slidably received through at least a portion of the capture device208. In FIG. 2A, the system 200 is shown in a low-profile or deliverystate in which both the capture device 208 and the cutting device 210are in a low-profile or delivery state. FIG. 2B shows a distal portionof the capture device 208 in a deployed state while the cutting device210 (not visible) remains in a low-profile state (and/or has not yetbeen advanced to the distal portion of the capture device 208). FIGS. 2Cand 2D are isometric views of the modifying system 200 with the capturedevice 208 in a deployed state and the cutting device 210 in first andsecond deployed states, respectively. As used to describe the any of theintraluminal tissue modifying systems herein, “deployed” or “expanded”state refers to the tissue modifying system when one or both of thecorresponding capture device and the corresponding cutting device are inthe expanded or deployed states.

Referring again to FIGS. 2A-2D together, the distal portions of thecapture device 208 and the cutting device 210 together comprise a tissuemodifying region 206 of the system 200. The tissue modifying region 206is transformable between a low-profile state (FIG. 2A) for deliverythrough an introducer sheath (or other delivery device) to a treatmentsite within a vessel lumen, and an expanded or deployed state (any ofFIGS. 2B-2D) for engaging and cutting tissue at the treatment site, asdescribed in greater detail below.

The capture device 208 can include an outer shaft 212 and an inner shaft214 disposed within a lumen of the outer shaft 212. The capture device208 and/or the inner shaft 214 may have an atraumatic distal end region250. As shown in FIGS. 2A-2D, one or more regions of the outer shaft 212have been removed along the distal portion to form expandable capturemembers 216. A distal end region of the outer shaft 212 can be fixed tothe distal end region 250 of the inner shaft 214. As such, proximalmovement of the inner shaft 214 with respect to the outer shaft 212pulls the distal portions of the capture members 216 proximally andforces the capture members 216 to bend outwardly away from thelongitudinal axis of the shaft 212, as shown in FIGS. 2C-2D.

The capture members 216 can include one or more segments (referred tocollectively as segments 201; labeled individually as first and secondsegments 216 a, 216 b) and one or more joints 217 (referred toindividually as first-third joints 217 a-c). The joints 217 can bepositioned along the capture members 216 between successive segments 201and/or at the portions of the capture members 216 that meet the shaft212 (e.g., the proximal and distal end portions of the capture members216). The joints 217 can be portions of the capture members 216 and/orshaft 212 configured to preferentially flex or bend relative to thesegments 201 and/or the shaft 212. In some embodiments, one or more ofthe joints 217 can be formed by opposing recesses at a desired locationalong the capture member 216 (e.g., a living hinge), and in otherembodiments one or more of the joints 217 can be one or more small pins,elastic polymeric elements, mechanical hinges and/or other devices thatenable one segment 201 to pivot or bend relative to another.

In the embodiment shown in FIGS. 2A-2D, each of the capture members 216includes a distal joint 217 a at its distal end portion, a proximaljoint 217 c (only labeled in FIGS. 2A and 2B) at its proximal endportion, and an intermediate joint 217 b positioned along the length ofthe respective capture member 216 between the distal and proximal joints217 a, 217 c. In response to longitudinal stresses caused by proximalmovement of the intermediate shaft 214, the capture members 216 deforminto a predetermined shape biased by the configuration and/or relativepositions of the joints 217. For example, in the illustrated embodiment,each of the capture members 216, when deployed, include a generallycurved distal segment 216 a and a generally curved, concave proximalsegment 216 b. The individual proximal segments 216 b extend outwardlyfrom the shaft 212 in a proximal direction, thereby forming a captureregion 280 between the respective proximal segment 216 b and the outershaft 212 and/or another portion of the proximal segment 216 b). In use,the capture members 216 and/or the proximal segments 216 b hook orcapture targeted tissue within the capture region 280 for subsequentcutting and/or other modification.

The cutting device 210 can be slidably received within a lumen of theinner shaft 214 of the capture device 208. The cutting device 210 caninclude an elongated shaft 213 (shown in dashed lines in FIG. 2C) andone or more cutting elements, such as blades 230, rotatably coupled to adistal portion of the shaft 213. In the embodiment shown in FIGS. 2A-2D,each of the blades 230 has a first end portion 230 a (shown in dashedlines in FIG. 2C), a second end portion 230 b opposite the first endportion 230 a, and a sharpened edge 231 that faces proximally when thecutting device 210 is in the deployed state. The first end portions 230a are rotatably coupled to a distal portion of the inner member 213 and,when the cutting device 210 is in a deployed state (such as the deployedstates shown in FIGS. 2C and 2D), the first end portions 230 a are (1)positioned proximal of the second end portions 230 b, and (2) positionedcloser to a central longitudinal axis of the inner member 213 than thesecond end portions 230 b. In the deployed state, the blades 230 extendoutwardly away from the central longitudinal axis of the shaft 213through slots 215 in the outer shaft 212 and corresponding slots 211 inthe intermediate shaft 214 to cut tissue at the treatment site. In use,the cutting device 210 can be deployed or expanded within an interiorregion enclosed by the capture members 216 of the capture device 208 andpulled proximally to cut the tissue. As the sharpened edge 231 cuts thetissue, the blades 230 provide additional tension on the tissue.

In one method of using the system 200, the tissue modifying region 206,in its low-profile delivery state, is positioned within a blood vessellumen at a treatment site, such as at or near one or more intraluminalstructures such as synechiae. The inner shaft 214 can then be pulledproximally relative to the outer shaft 212 to deploy the capture members216 of capture device 208 (or the outer shaft 212 can be moved distallyrelative to the inner shaft 214). Via deployment of the capture device208 and/or subsequent proximal axial movement of the system 200, thecapture members 216 capture one or more intraluminal structures (such assynechiae) for cutting.

Before, during, and/or after deployment of the capture members 216, thecutting device 210 can be deployed such that the blades 230 extendoutwardly away from a central longitudinal axis of the outer shaft 212(and through the slot 215 in the outer shaft and the slot 219 in theintermediate shaft 214) at an axial location that is distal to theproximal joint 217 c of the capture members 216 in preparation forcutting. As shown in FIGS. 2C and 2D, the cutting device 210 and/or theblades 230 can be pulled proximally towards the capture members 216 tocut the tissue which has been captured by the capture members 216. Theslots 215 along the capture device 208 and outer shaft 212 and the slots219 along the intermediate shaft 214 allow the cutting device 210 tomove proximally of interior region 280 enclosed by the capture members216. In this embodiment, the captured tissue can be held in tensionwhile the tissue is being cut by the blades 230 by pulling the capturedevice 208 proximally. The capture members 216 themselves may alsoprovide tension in an outward direction.

FIGS. 3A and 3B are isometric views of a distal portion of anintraluminal tissue modifying system 300 (“or modifying system 300”)configured in accordance with another embodiment of the presenttechnology, shown in a first and second deployed state. The componentsof the modifying system 300 can be generally similar to the componentsof the modifying system 200 shown in FIGS. 2A-2D except each of theblades 330 of the cutting device 310 of FIGS. 3A and 3B has a sharpenededge 331 that faces distally when the cutting device 310 is in thedeployed state (such as the first and second deployed states). As such,to cut tissue captured within the capture region 280 of the capturedevice 208, the cutting device 310 is pushed distally, as shown in FIG.3B. When the cutting device 310 is in a deployed state, the first endportions 330 a (shown in dashed lines in FIG. 3A) are (1) positioneddistal of the second end portions 330 b, and (2) positioned closer to acentral longitudinal axis of the inner member 313 (only shown in FIG.3A) than the second end portions 330 b. In use, the cutting device 310can be deployed or expanded proximal of the arms 216 of the capturedevice 208 and pushed distally through the slots 215 in the capturemembers 216 to cut the tissue in the capture region 280. As thesharpened edge 331 cuts the tissue, the blades 330 provide additionaltension on the tissue.

FIGS. 4 and 5 show yet another embodiment of an intraluminal tissuemodifying system 600 configured in accordance with the presenttechnology. In FIGS. 4 and 5, the system 600 is shown in a firstdeployed state and a second deployed state, respectively. The componentsof the modifying system 600 can be generally similar to those of themodifying system 200 shown in FIGS. 2A-2D, except (1) the capture device608 and cutting device 610 of system 600 form a capture region 680 thatfaces distally and (2) in use, the capture device 608 is pushed distallyto capture and tension tissue for cutting. Once the tissue has beencaptured, the cutting device 610 can be deployed or expanded distal tothe capture device 608, as shown in FIG. 4. As shown in FIG. 5, theblades 630 of the cutting device 610 can then be pulled proximally intothe capture device 608 to cut the intraluminal tissue. In otherembodiments, the capture device 608 may be utilized with thedistally-facing cutting device 310 shown in FIGS. 3A and 3B.

One advantage of the intraluminal tissue modifying systems of thepresent technology over conventional devices is that the modifyingsystems disclosed herein place the vessel wall (e.g., a vein wall) andintraluminal tissue in tension prior to cutting tissue. In someembodiments modifying systems herein, the tissue modifying region caninclude tensioning arms to provide additional radial tension. Forexample, FIG. 6 shows an embodiment of an intraluminal tissue modifyingsystem 400 having tensioning arms 440 coupled to the outer shaft 412.(Like numerals in FIG. 6 refer to like parts of the embodiment of FIGS.2A-2D). In other embodiments, the tensioning arms 440 can be separatecomponents and/or may be coupled to the inner shaft 414 and/or the shaft(not visible) of the cutting device 410. The additional tensioning arms440 may aid in cutting tissue, especially in vessels that haveparticularly bulky and/or tough fibrous tissue. In some embodiments, thetensioning arms 440 may be configured to expand radially wider than thecapture members 416, thereby reducing the chance of the cutting devicescutting the natural vessel wall during the cutting stage.

In any of the embodiments disclosed herein, the capture device and/orthe capture members may be made from a pair of coaxial tubes. Forexample, in some embodiments the outer shaft and capture members may beformed of a cut outer tube and the intermediate shaft is a tube slidablydisposed within the outer shaft such that axial movement of theintermediate shaft relative to the outer shaft (or vice versa) triggersdeployment of the capture members. In such embodiments, the outer shaftcan be made of a material and have a configuration that is appropriatefor being expanded from a straight profile to an expanded lateral orbi-lateral hook shape. Examples of suitable materials include flexiblepolymers such as nylons, polyethylene, polypropylene, and other polymersappropriate for living hinges, and/or combinations of any of theforegoing materials, which may include other polymers or fillers asappropriate to achieve the desired mechanical characteristics. Incertain embodiments, one or more components of the capture device may bemade of a flexible or superelastic metal, such as nitinol. The thicknessof the tube may determine the strength of the capture device. Forexample, the polymer materials utilized may not be as stiff andtherefore a tube wall thickness may be required to make a capture devicewith equivalent mechanical properties as one made from a nitinol hook.The cuts are configured such that when the tube is shortened (via, forexample, an inner actuator tube), the capture members form an outwardlyexpanding hook shape. In an embodiment, the struts/capture members forma “bi-stable geometry”; in other words, the struts are geometricallystable in either the collapsed state or in the fully expanded state whenthe tube is shortened and the proximal section of the struts have swungout past 90 degrees (which would occur if one section is longer than theother). The cut tube may also be heat set to a hooked shape, tofacilitate and encourage the tube to assume the hook shape when it isshortened.

The capture members of any of the capture devices disclosed herein canhave any suitable size and/or shape based on a desired bendingstiffness, angle, and radius of curvature. For example, FIGS. 7A-7C showseveral embodiments of capture members having different deployed shapes.In FIG. 7A, both the proximal segment 216 b and the distal segment 216 aof each of the capture members 216 is relatively straight, and angledradially inwardly. In FIG. 7B, the proximal segments 216 a of thecapture members 216 droop in a proximal direction. In FIG. 7C, thecapture members 216 are configured such that both the distal andproximal segments 216 a, 216 b curve outwardly away from thelongitudinal axis of the outer shaft 212, and then curve radiallyinwardly back towards the longitudinal axis of the outer shaft 212.

Moreover, the number of segments 201, the length of each segment 201,the angle between segments 201, and/or the shape of each segment 201(e.g., linear, curved, etc.) can be varied along a single capture memberand/or amongst a plurality of capture members. Additionally, in someembodiments, the capture members 216 may be separate components coupledto the outer shaft 212. Furthermore, the deployed shape of the capturemembers 216 and/or the amount of tissue separated by the capture members216 may be adjusted by varying the distance traveled by the inner shaft214 relative to the outer shaft 212 (or vice versa). Also, the cut edgesof the outer shaft 212 can be rounded, for example by electropolishingthe components.

In some embodiments of the present technology, the capture device is aself-expanding member made from spring material such as nitinol orspring steel. For example, FIG. 8A shows one embodiment of a capturedevice 808 constrained by a retaining sleeve 882 during deployment. Whenthe capture device 808 is at the target treatment site, the retainingsleeve 882 is pulled back (FIG. 8B), allowing the arms or capturemembers 816 of the capture device 808 to expand outwardly. A cuttingdevice (not shown) may then be expanded distal to the capture device 808and pulled proximally towards the capture device 808 to cut tissuecaptured within the capture region 880.

Embodiments of cutting devices will now be described in detail. FIG. 9Ashows one embodiment of a cutting device 910 comprised two blades 930that can be transformable between from a low-profile state (not shown)and a deployed or expanded state (as shown in FIG. 9A). In otherembodiments, the cutting device 910 can include more or fewer blades(e.g., one blade, three blades, four blades, etc.) As shown in FIG. 9A,the blades 930 are coupled to an elongated shaft 913 and an elongatedmember 940 (such as a pull or push rod) slidably received within a lumenof the elongated shaft 913. FIG. 9B shows an isolated view of the blades930 and inner member 940, and FIG. 9C shows an enlarged view of aportion FIG. 9B. Referring to FIGS. 9B and 9C together, each of theblades 930 are rotatably coupled to the outer shaft 913 via a first pin943 (or other coupling device(s)) that extends from one side the shaft913 across the gap 942 through the thickness of each of the blades 930and a slot 944 along the attachment region 946 of the inner member 940,and is fixed at an opposing side of the shaft 913. One end of the firstpin 943 sits within. The cutting device 910 further includes second pins941 a, 941 b (or other coupling device(s)), each of which extend through(and/or from) the corresponding blade 930 and through a correspondingslot 945 a, 945 b, respectively, along a distal coupling region 946 ofthe inner member 940. When the inner member 940 is moved axially withrespect to the shaft 913, the second pins 941 a, 941 b push the blades930 axially while the blades 930 rotate around the first pin 943.Similar mechanisms can be used for blades that are oriented in anopposite direction (e.g., with the sharpened edge of the blades facingproximally), as shown in the cutting device 1010 of FIG. 10. Otheractuation mechanisms are also possible to move the blades from alow-profile state to a deployed or expanded state.

Another embodiment of a cutting device is shown in FIG. 11. In thisembodiment, the blades 1130 are attached to secondary support arms 1131to add strength and rigidity to the blades during the cutting stage.When opened, the blades 1130 and support arms 1131 form a diamond shape.In some embodiments, both the distal and proximal segments of thediamond may have cutting edges, so that the cutting device 1110 can cutboth forwards (in a distal direction) and backwards (in a proximaldirection) into and out of the capture device. This configuration mayallow a “saw” like cutting motion to cut longer or more tougher sectionsof captured tissue, such as fibrotic septums. The cutting device 1110may be used in a proximal-facing modifying systems (such as systems 200and 300) and/or distal-facing systems (such as system 600).

Yet another embodiment of a cutting device is shown in FIGS. 12A and12B. In this embodiment, the blades 1230 are attached to expandablemembers formed from a cut tube 1213. An inner actuator tube 1240 pushesthe blades 1230 outward, as seen in FIG. 12B. The blades 1230 may beattached to the expandable members of cut tube 1213 via soldering,welding, etc. Alternately, the blades 1230 may be attached mechanically,for example via features such as hooks formed on the attachment side ofblade 1230 corresponding with slots on the cut tube 1213 and configuredsuch that the hooks lock securely into place when positioned in theslots. A variation of this embodiment is shown in the cutting device1310 of FIGS. 13A-13B. In this embodiment, the blades 1330 are attachedat only one end, and angled outward when the outer cut tube 1313 isshortened or deployed via the cutting device actuator tube 1340. Both ofthe cutting devices 1210 and 1310 have the advantage that they canmaintain an inner lumen, and thus not require removal of an innerelement such as a guide wire or imaging catheter during the cutting ofthe tissue.

FIGS. 14A-14C show another embodiment of a cutting device 1410configured in accordance with the present technology. The cutting device1410 utilizes energy to perform the cutting function. In the embodimentshown in FIGS. 14A-14C, the cutting device 1410 includes an expandablewire structure 1450 connected to an energy source 1452 (shownschematically), such as radiofrequency (RF) energy, ultrasound energy,plasma energy, and/or other suitable energy sources that can cut throughtissue on contact. The cutting device 1410 can also include an outershaft 1412 and an inner actuator 1440 (e.g., solid rod, hollow tube,etc.) that are coupled at their respective distal portions. As shown inFIG. 14B, the wire structure 1450 may be foreshortened via proximalmovement of the inner actuator 1440 that expands the wire structureoutwardly away from the longitudinal axis of the inner actuator 1440. Inthis expanded or deployed state, the wire structure 1450 is thenenergized and pulled towards the capture device (not shown) to cut thetissue. FIG. 14C shows a variation of the embodiment shown in FIGS.14A-14B. In FIG. 14C, the wire structure 1450 is selectively insulated,for example, with an outer coating or insulation layer 1458, to limitthe exposed cutting portion of the wire structure 1450.

Any of the cutting devices (or combinations thereof) may be used withany of the capture devices described herein as appropriate to perform anintraluminal tissue capture and cutting procedure.

In some embodiments of the intraluminal tissue modifying systemsdisclosed herein, the capture device and the cutting device may beintegrated into a single device such that the tissue capture and cuttingmay occur in a single step. Such a tissue modifying system may requireless components than, for example, the system 200 shown in FIGS. 2A-2D,and as a result, system 1500 may have a smaller profile. FIGS. 15A and15B, for example, show an intraluminal tissue modifying system 1500 (or“system 1500”) having a combined capture/cutting device 1507, shown in alow-profile delivery state and a deployed state, respectively. Thecomponents of the tissue modifying system 1500 can be generally similarto the components shown in FIGS. 2A-2D, except the system 1500 does notinclude a separate cutting device and instead the capture members 1516include cutting elements 1530 positioned along their proximal segments1516 b. In some embodiments, one or more of the cutting elements 1530may be separate components (e.g., blades) that are attached to thecapture members 1516 via soldering, welding, gluing, or other attachmentdevices. In these and other embodiments, one or more of the cuttingelements 1530 may be integral with/formed of the outer shaft 1512 (e.g.,not a separate component) and/or capture members 1516.

The cutting elements 1530 may be attached or integrated with all or someof the capture members 1516. Moreover, although the tissue modifyingsystem 1500 is shown having two capture members 1516, in otherembodiments the tissue modifying system 1500 may have more or fewercapture members (e.g., a single capture member, three capture members,four capture members, five capture members, etc.). For example, FIG. 16shows an intraluminal tissue modifying system 1600 generally similar tothe tissue modifying system 1500, except system 1600 has three capturemembers 1616, all of which individually include a cutting element 1530positioned along their respective proximal segments 1616 b.

In some embodiments, the system can include a cutting device attached tothe inner capture member surface which is an energized element, such asan RF, plasma, or ultrasonic electrode. In this embodiment, the energymay be applied after the intraluminal tissue has been captured and putinto tension by the capture member.

In any of the embodiments of intraluminal tissue modifying systemsdisclosed herein, the capture device and/or cutting device may have aninternal lumen that is sized to accommodate a guidewire and/or acatheter (e.g., a guidewire and/or catheter having a 0.035″ outerdiameter, a guidewire and/or catheter having a 0.038″ outer diameter,etc.). In such embodiments, the system may be delivered over theguidewire and/or a catheter to a target treatment site, and maysub-selectively guide an interventional catheter and/or imaging catheterduring the procedure. Examples of suitable catheters include imagingcatheters, such as intravascular ultrasound (IVUS) catheters, opticalcoherence tomography (OCT) catheters, angioscopes, and/or other imagingmodality, and interventional catheters, such as balloon catheters, stentdelivery systems, diagnostic angiographic catheters, thrombectomycatheters, and the like. Once the tissue modifying system is positionedat the treatment site (and/or sub-component thereof, such as a capturedevice and/or a cutting device), the guidewire can be removed andreplaced with a cutting device (for example, if the cutting device doesnot have a central lumen, such as the cutting device 210 shown in FIGS.2A and 2B), an imaging catheter, and/or an interventional catheter asneeded to capture, cut, and/or otherwise modify tissue at the treatmentsite. In those embodiments where the cutting device does have a centrallumen, the tissue cutting step can be performed without the need toexchange the guidewire for a cutting device. In these embodiments, theguidewire may still be exchanged for another catheter such as a ballooncatheter or stent delivery catheter for further tissue modification atthe treatment site or nearby site.

FIG. 17 shows another embodiment of an intraluminal modifying system1700 configured in accordance with the present technology. In FIG. 17,the system 1700 is shown positioned in a blood vessel V. The componentsof system 1700 can be generally similar to the components of system 200shown in FIGS. 2A-2D, except the system 1700 includes a distal occlusionballoon delivered through the lumen of the intermediate shaft 1714 andconfigured to block blood flow in the vessel V. As shown in FIG. 17, thesystem 1700 can be used with an angioscopic imaging catheter 1790. Clearsaline may be delivered to the target site (e.g., via a central lumen,an introducer sheath, a guide catheter, etc.). An angioscope 1790 may beplaced alongside the system 1700 and used to visualize the intraluminalfibers during the capture and cutting stages. Alternately, as shown inFIG. 18, the angioscope may be delivered via a distal access site alongwith an occlusion balloon to provide a view from distal to proximal ofthe treatment site.

In some embodiments, the intraluminal tissue modifying system may have alumen alongside the main actuation shaft. FIG. 19 depicts an embodimentof an intraluminal tissue modifying system 1900 with a lumen 1902running parallel to a main actuation shaft 1910, and a tissue modifyingregion 1906 at the distal portion of the main actuation shaft 1910. Thislumen 1902 is configured to function as a lumen to deliver an imagingand/or interventional catheter to the treatment site. In one version ofthis embodiment, the lumen 1902 runs the entire length of the systemfrom distal tip to proximal handle. As depicted in FIG. 19, the lumen1902 terminates distally at an opening 1911 that is proximal to thetissue modifying region 1906. A port on the proximal handle is attachedto the proximal end portion of lumen 1902, and terminates on theproximal end by a hemostasis valve to allow safe introduction of devicesin and out of this lumen. This lumen may also be used for contractinjection, flushing, and delivery of therapeutic agents such asthrombolytic agents. The addition of a lumen to the system may increasethe cross-sectional area of the device, but increases functionality ofthe system. It allows maintenance of guidewire access across the targetsite during the cutting stage, and/or allows peri-procedural imagingfrom an intravascular imaging device.

FIGS. 20A and 20B show another embodiment of an intraluminal tissuemodifying system 2000 configured in accordance with the presenttechnology. The system 2000 has a second lumen 2002 which runs alongsidethe length of the device including the distal section, and is thenrejoined to a first lumen 2004 at a distal portion of the device. Thisversion allows for simultaneous imaging during the tissue capture andtissue cutting stages of the procedure, thus providing a more accurateand reliable procedure. In this embodiment, the system 2000 has thefirst lumen 2004 through the main actuation shaft, and the second lumen2002 which combines with the first lumen 2004 just proximal to thedistal portion to create a single distal lumen 2006, such that there aretwo lumens in the system for the entire length of the system except forthe portion of the distal region that is axially aligned with theinterior region of the capture members 2016 in a deployed state. In use,the system 2000 is inserted over a guidewire 2090, which is disposed inthe first lumen 2004 and continues through the distal/combined lumen2006 and out the distal tip, as depicted in FIG. 20A. The cutting deviceis retracted so that it is fully in the second lumen 2002. Onepositioned, the capture members 2016 may be expanded outward to tensionthe desired tissue. The guidewire 2090 is then pulled back so that it isfully in the second lumen 2002. The cutting device 2010 can now beadvanced forward from the first lumen 2004 to the distal lumen 2006through the center of the expandable capture device 2008, and perform acutting stage. This version has a smaller crossing profile, which isdesirable in some instances.

Another embodiment of an intraluminal tissue modifying system is shownin FIG. 21. The tissue modifying system 2100 includes a distal-facingcapture device 2108 (generally similar to the capture device 608 shownand described with respect to FIGS. 4 and 5) and a two-sided cuttingdevice 2110 with blades 2130 configured in a diamond shape (generallysimilar to the cutting device 1110 shown and described with respect toFIG. 11). The cutting edges 2131 of the blades 2130 extend distal to thecapture members 2116 and are guided by a section of outer shaft 2112that extends distal to the capture members 2116. Slots 2115 in the outershaft 2112 and capture members 2116 allow the blades 2130 to cut andmove/slide through the capture device 2108. The cutting device 2110 maybe moved axially in both proximal and distal directions to cut tissue inboth directions while the tissue is being held in tension with thecapture members 2116.

FIGS. 22A-22C illustrate a variation of the embodiments shown in FIGS.20A and 20B and FIG. 21. The intraluminal tissue modifying system 2200of FIGS. 22A-22C includes an additional shaft 2203 running parallel tothe outer shaft 2212 along at least a portion of its length. The shaft2203 includes lumen 2204 (FIG. 22B). The lumen 2204 of the shaft 2203combines with the lumen 2222 of the outer shaft 2212 at a distal portionof the modifying system 2200 to form lumen 2206 (FIG. 22C). The lumens2204 and 2222 may combine, for example, at a location that is distal toa distal end of the slots 2215 in the outer shaft 2112. The lumen 2204may be configured to slidably receive a guidewire 2290 therethrough(e.g., a 0.035″ or 0.038″ guidewire), such that the system 2200 may bedelivered over the guidewire 2290 to a target site before and/or duringthe capture and cutting stages of the procedure.

In yet another embodiment, the system has a second lumen for a guidewireand a third lumen for imaging or interventional device. In this version,the cutting device and imaging can happen simultaneously whilemaintaining guidewire access across the target site. Similar to above,all three lumens may run the entire length of the device. Alternatively,the three lumens may combine into one lumen proximal to the distalsection, so that different elements can be advanced or pulled back asrequired during system access, peri-procedural or post-proceduralstages. Alternatively, the guidewire lumen and the cutting lumen cancombine into one lumen distally into one lumen at the distal tip of thedevice, but the third imaging lumen remains a separate lumen throughoutthe entirety of the device. Alternatively, the guidewire lumen and thecutting lumen can combine into one lumen distally into one lumen at thedistal tip of the device, but the third imaging lumen terminatesproximal to the distal section of the device, so that imaging can beperformed around the cutting and capture sections of the device.Alternatively, the guidewire lumen and the cutting lumen can combineinto one lumen distally into one lumen at the distal tip of the device,but the third imaging lumen contains a “window” or material speciallydesigned to be imaged there through near the distal section as describedpreviously.

In any of the embodiments which including intravascular imagingcapabilities, the lumen for the imaging catheter is configured tominimize interference with obtaining a good image. For example,materials used to create the lumen can be constructed from echolucent orradiolucent materials, or alternately “windows” are cut out of the lumenwall at the appropriate section. In some embodiments a “window” orsection specifically designed for imaging therethrough is placedspecifically at a location along the length of the device thatcorresponds with the capture members' curved joints when the capturedevice is in the deployed or expanded state. In other embodiments, the“window” or section specifically designed for imaging therethrough spansa length that extends proximal to and distal to the length of the devicethat corresponds with the capture members' curved hinge points when thedevice is in the deployed or expanded state. These embodiments have theadvantage of allowing the user of the device to image the tissue to becaptured around the same section of vein where the capture devicesreside, so that the device can be rotated to an appropriate angle tomore effectively capture the tissue.

All embodiments describing different configurations of multiple lumensapply to systems having or configured to receive proximal-facing cuttingdevices and/or systems having or configured to receive distal-facingcutting devices.

In some procedures, it may be desirable to utilize an expandable memberwhile cutting tissue. In this instance, the tissue cutting stage may bea beneficial pre-procedural stage before balloon dilatation of anobstructed or partially obstructed vein. As described above, the systemmay have a lumen which can be used to deliver a catheter having anexpandable member, such as a balloon or expandable cage, to the sitewhere venous synechiae has been cut through by the capture and cuttingstages. In another embodiment, as shown in FIG. 23, the system 2300 hasan expandable member, such as an inflatable dilatation balloon element2370, slidably or permanently attached to the system. As shown in FIG.23, the dilatation balloon element 2370 may be positioned distal to thecapture device 2308. Alternately, the dilatation balloon element 2370may be positioned proximal to the capture device 2308. The dilatationballoon element 2370 can be moved distally or proximally after thecutting stage to perform a balloon dilatation step without needing toexchange devices and re-access the treatment site during the procedure.In this embodiment, the system 2300 has an additional lumen to couplethe expandable member 2370 to an actuator. For example, in thoseembodiments where the expandable member 2370 is a balloon, theadditional lumen may be an inflation lumen coupled to apressure-generating device. The balloon material may be non-compliant,semi-compliant, or compliant, to be used for either dilatation of thevessel or occlusion of the vessel, for example when used in conjunctionwith an angioscope, or to be used for both purposes during differentparts of the procedure. Examples of non-compliant or semi-compliantballoon materials include polyethylene, nylon, polyurethane, polyamidesor blends of these materials. Examples of compliant balloon materialsinclude low durometer polyurethanes, silicone rubber, latex, or blendsof these materials. In those embodiments where the expandable member2370 is an expandable cage (e.g., a nitinol cage), a pull-wire or pushrod or other connecting member may extend distally from the handle 2320through the additional lumen 2327 to the expandable cage at the distalportion of the system 2320.

Any of the systems disclosed herein may be configured to treat a rangeof vessel sizes. For example, in some embodiments the system can beconfigured to treat veins having an inner diameter from about 5 mm toabout 35 mm. In another embodiment, the system comes in a range ofsizes, each able to treat a corresponding vein inner diameter range, forexample a small size system can treat veins from about 5 mm to about 12mm, a large size can treat veins about 10 mm to about 18 mm, and yet athird size can treat about 15 mm to about 23 mm. As is noted, the sizeranges overlap so that there is a greater possibility that only onedevice size can be used to treat a patient with a range of vein sizes.In another example, two sizes of systems can treat two overlappingranges of vein sizes that covers the desired range of vessels to betreated.

Disclosed now are methods of use of this system. In a first stage, theintravascular tissue modifying system is inserted into a vein andadvanced to a target treatment site over a 0.035″ guidewire. The systemmay be inserted from a femoral vein and advanced in a retrograde fashionto a target leg vein. Alternately, the system may be inserted in adistal leg vein, for example a tibial or popliteal vein, and advanced inan antegrade fashion to a target site.

Once at or near the target site, the guidewire may be exchanged for anintravascular imaging catheter. The system may be guided over theimaging catheter to the target site, using the imaging information. Inthe embodiment with two or more lumens, the guidewire may remain inplace or be pulled back out of the distal portion and the imagingcatheter is advanced. Alternately, an imaging catheter may be placedside by side with the system at the target site to aid in positioning.In an embodiment, the imaging system is angioscope. In this methodembodiment, as shown in FIG. 17, the central lumen may be used todeliver a balloon catheter and provides occlusion to blood flow to allowflushing the treatment area with clear saline. Alternately, the systemhas an integrated or built-in balloon catheter to perform the occlusionfunction. Alternately, as a balloon catheter is delivered via a distalaccess site and advanced to a position distal to the treatment site toprovide blood occlusion as required to create a clear viewing area forthe angioscope. The angioscope may be positioned side by side with thesystem in the vessel through the same introducer sheath, or be deliveredthrough a secondary lumen in the system. Alternately, as shown in FIG.18, the angioscope may be delivered via a distal access site along withan occlusion balloon to provide a view from distal to proximal of thetreatment site.

In a second stage, the expandable capture device is expanded and gentlypulled proximally until resistance is met. Capture of intraluminaltissue may be confirmed via the imaging catheter, external ultrasound,and/or tactile feedback of resistance to movement.

In a third stage, a cutting device is advanced and expanded. In theembodiment with a single internal lumen, the imaging catheter is removedto advance the cutting device. Alternately, in other embodiments, theimaging catheter may remain in place or positioned next to the systemduring cutting device advancement. Once the cutting device is expanded,it can be pulled back (proximally) towards the capture device to cutintraluminal tissue. Additional capture and cutting stages may beperformed in the same or different target sites in the veins, usingintravascular and external imaging methods as guidance to completesufficient excision of the intraluminal tissue.

Variations of capture and cutting stages are possible with differentembodiments. Additional interventions such as balloon dilatation orstent implantation may be performed during or after the tissue cuttingstages in the same procedure.

In the embodiment with a combined tissue cutting and balloon dilatationdevice, once the tissue is cut the balloon is positioned at the targetsite and a balloon is inflated to perform a vessel dilatation stage.Tissue cutting and balloon dilatation may be repeated as necessary toachieve a desired hemodynamic stage.

Imaging modalities such as IVUS, OCT, and/or angioscopy may be utilizedas adjuncts to the positioning, capture, and/or cutting stages of themethods disclosed herein.

The devices and systems of the present technology are configured toeasily capture and cut through dense and fibrous tissue, partiallyobstructive tissue in veins, without causing injury to the native veinwall. The devices and systems of the present technology are alsoconfigured to put anatomical structures in tension during cutting toimprove the accuracy and efficiency of the resulting cut. The devicesand systems of the present technology are configured to cut anatomicalstructures without being pulled out of the target treatment site, sothat repeat cuts can be done without having to re-cross or re-access aparticular site.

Conclusion

Although many of the embodiments are described above with respect todevices, systems, and methods for intravascular creation of autologousvenous valves and/or valve leaflets, other applications and otherembodiments in addition to those described herein are within the scopeof the technology. For example, the devices, systems, and methods of thepresent technology can be used in any body cavity or lumen or wallsthereof (e.g., arterial blood vessels, venous blood vessels, urologicallumens, gastrointestinal lumens, etc.) and used for surgical creation ofautologous valves as well as repair of autologous and/or syntheticvalves. Additionally, several other embodiments of the technology canhave different states, components, or procedures than those describedherein. For example, although several embodiments of the presenttechnology include two capture members and/or two blades, in otherembodiments the capture device and the cutting device can have more orfewer than two capture members and/or two blades, respectively (e.g.,one capture member, three capture members, four capture members, etc.)(e.g., one blade, three blades, four blades, etc.) For example, in someembodiments, the capture device and/or the cutting device can include asingle capture member or blade, respectively, having a first portionconfigured to extend laterally away from the longitudinal axis of theshaft in a first direction and a second portion configured to extendlaterally away from the longitudinal axis of the shaft in a seconddirection opposite the first direction. Moreover, it will be appreciatedthat specific elements, substructures, advantages, uses, and/or otherfeatures of the embodiments described with reference to FIGS. 1-23 canbe suitably interchanged, substituted or otherwise configured with oneanother in accordance with additional embodiments of the presenttechnology. For example, the tensioning arms described with reference toFIG. 6 can be combined with any of the modifying systems disclosedherein. Likewise, the cutting devices described in FIGS. 9A-14C can becombined with any of the capture members, tensioning arms, and/orcapture devices described herein.

Furthermore, suitable elements of the embodiments described withreference to FIGS. 1-23 can be used as standalone and/or self-containeddevices. A person of ordinary skill in the art, therefore, willaccordingly understand that the technology can have other embodimentswith additional elements, or the technology can have other embodimentswithout several of the features shown and described above with referenceto FIGS. 1-23. For example, the intraluminal tissue modifying devices,systems, and methods of the present technology can be used with any ofthe devices, systems, and methods disclosed in U.S. patent applicationSer. No. 13/035,752, filed Feb. 2, 2011, U.S. patent application Ser.No. 13/926,886, filed Jun. 25, 2013, U.S. patent application Ser. No.13/035,919, filed Feb. 25, 2011, U.S. patent application Ser. No.13/450,432, filed Apr. 19, 2012, U.S. patent application Ser. No.14/377,492, filed Aug. 7, 2014, PCT Application No. PCT/US2014/011209,filed Jan. 10, 2014, U.S. patent application Ser. No. 14/499,969, filedSep. 26, 2014, U.S. Provisional Patent Application No. 61/969,262, filedMar. 24, 2013, U.S. Provisional Patent Application No. 61/969,263, filedMar. 24, 2013, U.S. patent application Ser. No. 14/759,797, filed Jul.8, 2015, U.S. patent application Ser. No. 14/498,969, filed Sep. 26,2014, U.S. patent application Ser. No. 14/667,201, filed Mar. 24, 2015,U.S. patent application Ser. No. 14/667,670, filed Mar. 24, 2015, U.S.patent application Ser. No. 14/972,006, filed Dec. 16, 2015, U.S.Provisional Patent Application No. 62/317,470, filed Apr. 1, 2016, andU.S. Provisional Patent Application No. 62/345,687, filed Jun. 3, 2016,all of which are incorporated by reference herein in their entireties.

1-20. (canceled)
 21. A method for modifying intraluminal tissue, themethod comprising: intravascularly delivering a distal portion of anelongated shaft to a treatment site within a blood vessel; deploying acapture member at the distal portion such that the capture member bendsoutwardly away from a longitudinal axis of the elongated shaft andincludes (a) a generally curved distal segment extending between adistal joint and an intermediate joint, and (b) a generally curved,concave proximal segment extending between the intermediate joint and aproximal joint; and capturing intraluminal tissue of the blood vesselwith the proximal segment of the capture members.
 22. The method ofclaim 21 wherein: the capture member is one of a plurality of capturemembers; the elongated shaft is an outer shaft; and deploying theplurality of capture members comprises moving an inner shaft disposedwithin the outer shaft in a proximal direction relative to the outershaft, wherein a distal end region of the inner shaft is fixed to adistal end region of the outer shaft such that proximal movement forcesthe capture members to bend outwardly.
 23. The method of claim 22wherein the outer shaft includes a plurality of slots extending along alength of the distal portion, and wherein portions of the outer shaftbetween the slots define the capture members, and wherein moving theinner shaft in the proximal direction pulls distal portions of thecapture members proximally to force the capture members to bendoutwardly.
 24. The method of claim 21 wherein deploying the capturemember causes the capture member to preferentially flex or bend at eachof the distal, proximal, and intermediate joints.
 25. The method ofclaim 21, further comprising: deploying a cutting element from thedistal portion of the elongated shaft such that the cutting elementextends outwardly away from the central longitudinal axis of theelongated shaft at a location proximate to the proximal segment of thecapture member; and cutting the intraluminal tissue with the cuttingelement.
 26. The method of claim 25 wherein deploying the cuttingelement comprises deploying the cutting element from a position proximalto the proximal segment of the capture member.
 27. The method of claim25 wherein deploying the cutting element comprises deploying the cuttingelement from a position distal to the proximal segment of the capturemember.
 28. The method of claim 21, further comprising: placing theintraluminal tissue in tension with the proximal segment of the capturemember; deploying a cutting element from a position proximal to theproximal segment of the capture member .such that the cutting elementextends outwardly away from the central longitudinal axis of theelongated shaft and slides distally through an elongated opening in theproximal segment to cut the intraluminal tissue.
 29. The method of claim28 wherein: the elongated shaft is an outer shaft; the cutting elementis one of multiple cutting elements; deploying the multiple capturemembers comprises moving an inner shaft disposed within the outer shaftin a proximal direction relative to the outer shaft, wherein a distalend region of the inner shaft is fixed to a distal end region of theouter shaft such that proximal movement forces the capture member tobend outwardly; the method further comprises— deploying cutting elementsthrough slots in the outer shaft such that the cutting elements extendoutwardly away from the central longitudinal axis of the elongatedshaft; and cutting, with at least one of the cutting elements, theintraluminal tissue proximate to at least one of the proximal segments.30. The method of claim 21, further comprising: deploying cuttingelements radially outwardly away from the central longitudinal axis ofthe elongated shaft; and rotating the cutting elements to cut theintraluminal tissue proximate to the proximal segments.
 31. The methodof claim 21, further comprising: deploying cutting elements radiallyoutwardly away from the central longitudinal axis of the elongatedshaft; and moving the cutting elements proximally relative to thecapture member to cut tissue.
 32. The method of claim 21, furthercomprising expanding tensioning arms to extend outwardly away from theelongated shaft, wherein the tensioning arms are radially offset fromthe capture member to increase radial tension on the blood vessel. 33.The method of claim 21 wherein: intravascularly delivering the distalportion of the elongated shaft to the treatment site within the bloodvessel comprises positioning the distal portion in a vein; and themethod further comprises cutting fibrous intraluminal tissue with acutting element deployed form the distal portion of the elongated shaft.34. A method for modifying intraluminal tissue, the method comprising:intravascularly delivering a distal portion of an elongated shaft to atreatment site within a blood vessel; deploying capture members at thedistal portion of the elongated shaft such that the capture membersextend outwardly away from a longitudinal axis of the elongated shaftand place a wall of the blood vessel in tension, wherein each capturemember includes a distal joint at its distal terminus, a proximal jointat its proximal terminus, an intermediate joint positioned along itslength between the distal and proximal joints, and proximal segmentextending between its intermediate joint and its proximal joint;deploying cutting elements at the distal portion of the elongated shaftsuch that the cutting elements extend outwardly away from thelongitudinal axis of the elongated member; and cutting the intraluminaltissue with the cutting elements.
 35. The method of claim 34 whereincutting the intraluminal tissue comprises moving the cutting elementsthrough corresponding elongated openings in the proximal segments to cutthe intraluminal tissue.
 36. The method of claim 35 wherein deployingthe cutting elements further comprises: deploying the cutting elementsfrom a position proximal to the capture members; and moving the cuttingelement in a distal direction such that the cutting elements movethrough the corresponding elongated openings.
 37. The method of claim 35wherein deploying the cutting elements further comprises: deploying thecutting elements from a position distal to the proximal segments of thecapture members; and moving the cutting element in a proximal directionsuch that the cutting elements move through the corresponding elongatedopenings.
 38. The method of claim 34 wherein the elongated shaft is anouter shaft, and wherein deploying the capture members comprises: movingan inner shaft disposed within the outer shaft in a proximal directionrelative to the outer shaft, wherein a distal end region of the innershaft is fixed to a distal end region of the outer shaft such thatproximal movement forces each of the capture members away from the outershaft and each of the proximal segments is concave towards the outershaft to define a capture region.
 39. The method of claim 38 whereindeploying the cutting elements comprises expanding the cutting elementsradially outwardly from a cutting shaft slidably disposed within theinner shaft such that the cutting elements extend through correspondingslots in the inner and outer shafts.
 40. A method for modifyingintraluminal tissue, the method comprising: intravascularly delivering adistal portion of an elongated shaft to a treatment site within a bloodvessel, the distal portion a capture member; moving the capture memberfrom a low-profile state to a deployed state in which the capture memberextends outwardly away from a longitudinal axis of the elongated shaftto place a wall of the blood vessel in tension, wherein the capturemember includes a distal joint at its distal terminus, a proximal jointat its proximal terminus, an intermediate joint positioned along itslength between the distal and proximal joints, and proximal segmentextending between its intermediate joint and its proximal joint; andcapturing the intraluminal tissue within a capture region formed by theproximal segment of the capture member; and deploying a cutting elementat the distal portion of the elongated shaft such that the cuttingelement extends outwardly away from the longitudinal axis of theelongated member to cut the intraluminal tissue.
 41. The method of claim40 wherein moving the capture member to the deployed state causes theproximal segment to be concave toward the outer shaft.